Why You Need a Product License Holder to Import and Distribute to Indonesia

Indonesia’s stringent import regulations make it impossible for foreign companies to register or distribute products without a local entity. This is where the product license holder becomes a necessity.  

A product license holder in Indonesia is a legally appointed local company that handles product registration, compliance management, and import and distribution oversight. 

Without a product license holder, your product is barred from the market, especially if it’s a regulated item like cosmetics, food, beverages, supplements, or medical devices. 

What is a Product License Holder in Indonesia and Why It Matters 

A local Indonesian entity that assumes legal responsibility for foreign products is a product license holder. This entity acts on your behalf to: 

• Register products with Indonesian authorities (e.g., BPOM or the Ministry of Health)
• Ensure compliance with local documentation and regulations 
• Handle safety reporting, audits, and post-market obligations 

If your business lacks a local presence, appointing a license holder in Indonesia is mandatory.

The Role of a Product License Holder in Importing and Distribution 

Here’s how a product license holder in Indonesia supports your operations: 

Holds Exclusive Regulatory Authority 

Only one entity can be the license holder responsible for securing the Distribution Approval Number required for product entry. 

Must Meet Local Licensing Requirements 

To qualify, the license holder must be a registered Indonesian company with: 

• A Medical Device Distribution License (IDAK) 
• GDPMD (CDAKB) certification 

Can Be a Subsidiary, Distributor, or Independent Third Party 

Approved entities include: 

• A local subsidiary 
• A licensed distributor 
• An independent third party (e.g., Asia Actual, certified IPAK) 

Maintains Operational Control 

Your license holder handles: 

• Legal representation 
• Product registration 
• Import compliance 
• Distribution oversight 
• Post-market responsibility

READ MORE:

• Halal Registration: Your Guide to Product Registration
• SNI License and Product Registration in Indonesia
• Product Registration in Indonesia: How to Register Products via BPOM

When a Product License Holder is Mandatory 

Appointing a product license holder in Indonesia is not just a choice; it’s a legal requirement in many cases. A license holder becomes essential if you’re a foreign company looking to enter the Indonesian market without setting up a local entity.  

It’s a crucial step that ensures your product can legally enter and operate in the Indonesian market. Here’s when a product license holder is mandatory: 

• Company Based Outside Indonesia: Foreign businesses cannot register products directly with BPOM or the Ministry of Health. 
• Importing Regulated Products: Items like cosmetics, food, supplements, and medical devices must be registered by a local entity. 
• No Local Legal Entity: A third party without an Indonesian business must act on your behalf. 
• Independent Distribution Control: An independent license holder service allows flexibility without tying you to one distributor. 
• Compliance with BPOM or MoH: These agencies require the license holder to manage safety reporting and post-market obligations. 

The product license becomes your gateway to legally entering and operating the Indonesian market. 

Top Reasons to Appoint a Product License Holder in Indonesia 

Indonesia’s regulatory system is strict regarding product importation and distribution. Your product cannot legally enter the market without a locally registered product license holder. Here’s why appointing a license holder in Indonesia is essential: 

Legal Market Access and Product Registration 

Foreign companies cannot register products directly with the Badan Pengawas Obat dan Makanan (BPOM) or the MoH (for medical devices) unless they have a local entity. A local license-holder acts on your behalf for the registration process, including obtaining the required Distribution Approval Number. 

Full Regulatory Compliance 

In Indonesia, the license holder is the official local contact, handling all regulatory‐agency interactions, documentation, imports, distribution permits, and post‑market obligations. They must also ensure compliance with Indonesian regulations such as good distribution practices, import licensing, and local business registration. 

Maintain Market Flexibility 

Indonesia doesn’t allow license transfers or multiple product registrations; whoever holds the license effectively controls distribution. Using an independent, locally registered license holder will enable you to change distributors or scale operations without re‑registering the product. 

How InCorp Indonesia Supports as a Product License Holder 

InCorp Indonesia (an Ascentium Company) offers comprehensive license holder services, leveraging our expertise to help foreign companies import and distribute products in compliance with Indonesian regulations. As an independent product license holder, InCorp gives you complete control over your product without tying you to a single distributor. 

Product Registration and Compliance 

InCorp manages the entire product registration process with the relevant authorities. Our team: 

• Handles end-to-end registration with BPOM or MoH 
• Secures NIE and ensures document accuracy 
• Maintains ongoing license compliance 

Post-Registration Support 

Once your product is registered, InCorp acts as the regulatory liaison, such as: 

• Manages renewals, updates, and regulatory audits 
• Handles recall, safety alerts, and agency reporting 

Distributor Coordination and Market Oversight 

InCorp allows you to appoint and switch distributors freely, such as: 

• Allows you to appoint or replace distributors 
• Keeps registration independent of local partners 
• Ensures whole brand and market control

Enter Indonesia Without Losing Control with InCorp 

Appointing a product license holder is crucial for legally importing and distributing in Indonesia. InCorp Indonesia (an Ascentium Company) offers end-to-end support while letting you retain complete control of your product, such as: 

• Product Registration: Register all regulated products (medical devices, food, cosmetics, supplements, etc.) with BPOM and the Ministry of Health. 
• Import Permits & Importer of Record: If you don’t have a local entity, obtain the proper import licenses or use the Importer of Record service. 
• SNI & Halal Certification: Ensure compliance with national (SNI) and halal standards where required. 
• Trademark Registration: Protect your brand legally in Indonesia. 

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